XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer

NCT07593872 | Not Yet Recruiting

• 1 other identifier: 202602094DINA
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-arm, prospective feasibility study evaluates an Extended Reality (XR) headset-based preoperative surgical planning workflow that fuses 18F-FDG PET metabolic hotspots with CT anatomy on the OpVerse platform, in patients with non-small cell lung cancer (NSCLC) and supraclavicular or cervical lymph node metastasis (N3 disease) requiring lymph node dissection. Ten participants will undergo standard preoperative contrast-enhanced CT and whole-body PET. Synapse 3D software is used to segment key anatomic structures (clavicle, sternocleidomastoid, internal jugular vein, subclavian vessels, brachial plexus) and to project PET SUV hotspots onto the high-resolution CT model, yielding a patient-specific digital twin of functional tumor boundaries and at-risk neurovascular structures. Immediately prior to skin incision, the operating surgeon dons an XR head-mounted display (HoloLens via OpVerse) and registers the digital twin to the patient's neck using stable bony landmarks (clavicular head, sternal notch, mastoid). The surgeon plans the optimal incision and initial dissection trajectory, avoiding superficial veins and projecting the location of deep PET-positive nodes. The XR device is then removed, and the planned cervical or supraclavicular lymph node dissection is performed using standard surgical technique without further intraoperative XR guidance. The primary endpoint is a composite of safety and feasibility: absence of Grade ≥2 (Clavien-Dindo) phrenic nerve, brachial plexus, chyle leak, Horner syndrome, or major vascular injury through 30 days postoperatively, together with successful XR registration and incision planning. Secondary endpoints include incision planning accuracy, PET hotspot clearance rate, target registration error, operative time, estimated blood loss, and lymph node yield.

Conditions

Non-Small Cell Lung Cancer; Lymph Node Metastasis; Supraclavicular Lymph Node Metastasis

Keywords

Extended Reality; Augmented Reality; Surgical Navigation; PET/CT Fusion; Image-Guided Surgery; Digital Twin; Lymph Node Dissection; Mixed Reality

Outcome Measures

Primary Outcomes (1)

• Successful Completion of XR-Assisted Preoperative Surgical Planning Workflow

  Proportion of participants in whom the complete XR-assisted preoperative planning workflow is successfully executed, defined as meeting ALL of the following technical criteria: 1. Successful import and rendering of the patient-specific PET/CT fused 3D digital twin (OBJ/STL format) on the OpVerse platform via the HoloLens head-mounted display. 2. Successful surface registration to the patient's bony landmarks (clavicular head, sternal notch, mastoid) with a Target Registration Error (TRE) of 5 mm or less. 3. Successful surgeon-performed marking of the optimal skin incision and initial dissection trajectory prior to skin incision. The endpoint is reported as the percentage of cases (out of 10) meeting all three criteria.

  Intraoperatively, prior to skin incision (Day 0)

Secondary Outcomes (6)

• Incidence of Procedure-Related Adverse Events

  From surgery through 30 days postoperatively

• Surgeon-Assessed Adequacy of XR-Planned Surgical Incision (3-Point Categorical Scale)

  Intraoperatively, at time of skin incision and during initial dissection (Day 0)

• PET Hotspot Clearance Rate

  At time of surgery

• Target Registration Error (TRE)

  At time of surgery

• Operative Time

  At time of surgery

Study Arms (1)

XR-Assisted Surgical Planning

EXPERIMENTAL

Patients undergo XR-assisted preoperative incision planning using the OpVerse platform with HoloLens HMD, overlaying a PET/CT-fused 3D digital twin onto the patient's neck before skin incision. The XR device is then removed, and standard cervical/supraclavicular lymph node dissection is performed without intraoperative XR guidance.

Device: OpVerse XR Surgical Planning Platform with HoloLens HMD; Procedure: Cervical / Supraclavicular Lymph Node Dissection

Interventions

OpVerse XR Surgical Planning Platform with HoloLens HMD DEVICE

An offline workflow in which patient-specific PET/CT-fused 3D models built in Synapse 3D are exported to OBJ/STL format and rendered via the OpVerse platform on a HoloLens head-mounted display. The surgeon performs surface registration to bony landmarks of the neck and shoulder for preoperative incision planning. The device is removed prior to skin incision and is not used during the sterile dissection.

XR-Assisted Surgical Planning

Cervical / Supraclavicular Lymph Node Dissection PROCEDURE

En bloc systematic resection of fibrofatty tissue and metastatic lymph nodes within the cervical or supraclavicular region, performed using standard open surgical technique after XR-assisted incision planning.

XR-Assisted Surgical Planning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years.
• Confirmed or highly suspected lung cancer with supraclavicular or cervical lymph node metastasis requiring lymph node dissection.
• Willing to undergo preoperative PET/CT imaging.
• Able to provide written informed consent.

You may not qualify if:

• Prior high-dose radiation therapy to the neck causing severe distortion of cervical anatomy.
• Inability to undergo imaging studies, or known allergy to iodinated contrast media.
• Vulnerable populations as defined by local IRB regulations (e.g., pregnant women, prisoners, individuals lacking decisional capacity).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (7)

• Ueda K, Tanaka T, Hayashi M, Tanaka N, Li TS, Hamano K. What proportion of lung cancers can be operated by segmentectomy? A computed-tomography-based simulation. Eur J Cardiothorac Surg. 2012 Feb;41(2):341-5. doi: 10.1016/j.ejcts.2011.05.034. Epub 2011 Dec 12.

  PMID: 21703862 BACKGROUND

• Jensen K, Ringsted C, Hansen HJ, Petersen RH, Konge L. Simulation-based training for thoracoscopic lobectomy: a randomized controlled trial: virtual-reality versus black-box simulation. Surg Endosc. 2014 Jun;28(6):1821-9. doi: 10.1007/s00464-013-3392-7. Epub 2014 Jan 18.

  PMID: 24442678 BACKGROUND

• Hu Y, Malthaner RA. The feasibility of three-dimensional displays of the thorax for preoperative planning in the surgical treatment of lung cancer. Eur J Cardiothorac Surg. 2007 Mar;31(3):506-11. doi: 10.1016/j.ejcts.2006.11.054. Epub 2007 Jan 16.

  PMID: 17223351 BACKGROUND

• Bakhuis W, Sadeghi AH, Moes I, Maat APWM, Siregar S, Bogers AJJC, Mahtab EAF. Essential Surgical Plan Modifications After Virtual Reality Planning in 50 Consecutive Segmentectomies. Ann Thorac Surg. 2023 May;115(5):1247-1255. doi: 10.1016/j.athoracsur.2022.08.037. Epub 2022 Sep 6.

  PMID: 36084694 BACKGROUND

• Sato M, Kobayashi M, Kojima F, Tanaka F, Yanagiya M, Kosaka S, Fukai R, Nakajima J. Effect of virtual-assisted lung mapping in acquisition of surgical margins in sublobar lung resection. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1691-1701.e5. doi: 10.1016/j.jtcvs.2018.05.122. Epub 2018 Jul 20.

  PMID: 30248803 BACKGROUND

• Sadeghi AH, Mathari SE, Abjigitova D, Maat APWM, Taverne YJHJ, Bogers AJJC, Mahtab EAF. Current and Future Applications of Virtual, Augmented, and Mixed Reality in Cardiothoracic Surgery. Ann Thorac Surg. 2022 Feb;113(2):681-691. doi: 10.1016/j.athoracsur.2020.11.030. Epub 2020 Dec 19.

  PMID: 33347848 BACKGROUND

• Zheng YA, Lee YC, Huang JY, Hsieh HY, Chen YS, Chiang XH, Han PH, Lin MW, Hsu HH, Hung YP, Chen JS. Enhancing three-dimensional anatomical understanding in complex thoracic surgery: a comparative study of OpVerse and Synapse 3D. Eur J Cardiothorac Surg. 2025 Mar 28;67(4):ezaf069. doi: 10.1093/ejcts/ezaf069.

  PMID: 40163682 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin-Shing Chen

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Hsiang Chang

CONTACT

+886-2-2312-3456; changch1986@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share